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Implementation Trial In patieNts With rEnal failuRe and diAbetes for Major Adverse reNal and Cardiovascular Events (ITINERANCE)

2. juni 2026 oppdatert av: Nantes University Hospital

The goal of this clinical study is to establish if the use of public health-related messages, designed and disseminated to a targeted population, will result in tangible improvements in patient outcomes and healthcare practices.

Specific health-related messages oriented towards patients, through their biological results and HealthCare Professionals (HCPs), will be sent to participants included in the intervention group. The control group will not receive any health-related message (routine care).

The aim is to evaluate if this intervention leads to differences in Major Adverse Renal and Cardiovascular Events (MARCE), compared to routine care (no dissemination of health messages) in patients suffering in diabetes and renal failure.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

125000

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Main inclusion criteria:

  • Subject attending a ML participating to the study
  • Subject presenting a HbA1c ≥ 6.5% and an estimated GFR (CKD-EPI formula) in the range 60 to 15 ml/min (included) and/or albumin to creatinine ratio ≥ 300 mg albumin/g creatinine (or 30 mg/mmol creatinine), on the same biological determination.

Main exclusion criteria:

  • Subject previously identified as opposed to the use of their medical data and/or access of their SNDS data,
  • Subject not registered to the French social security system,
  • Subject with estimated GFR < 15 ml/min on the day of inclusion

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: health-related arm

Participants will receive an health-related message included in the biological results form. A short graphical illustration will indicate the patient-risk level according the biological results and video detailing national recommendations.

HCPs will receive a SIGNAL BIO message which was elaborated on evidence-based treatments and/or strategy for patients with diabetes.
Annen: Health-related messages
Patient will be included in the intervention according to the laboratory's randomization arm.The intervention consists in delivering patient information messages in laboratory reports, providing access to an educational video for patients and a specific message for the prescribing physician in the intervention arm, without modifying patient care.
Ingen inngripen: Control group
Participants will get as in the routine care, no message will be disseminated for this group.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Major Adverse Renal and Cardiovascular Events (MARCE) occurrence
Tidsramme: 2 years after randomization and dissemination of health-related messages

Change in Major Adverse Renal and Cardiovascular Events (MARCE) occurrence defined as a composite outcome including the following items (first occurring):

  • All-cause death
  • Myocardial infarction (universal definition)
  • Stroke (universal definition)
  • Sustained (over 45 days) use of renal replacement therapy
  • Heart failure leading to hospitalization (definition by the European Society of Cardiology)
2 years after randomization and dissemination of health-related messages

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Specific health outcomes
Tidsramme: 2 years after the randomization and dissemination of health-related messages

Change in specific health outcomes (separately analysed):

  • All-cause death
  • Myocardial infarction
  • Stroke
  • Sustained (over 1 month) use of renal replacement therapy
  • Heart failure leading to hospitalization
  • Lower limb amputation, with special information on the site of amputation (toe, transmetatarsal, transtibial, transfemoral)
  • Arterial revascularization in the coronary, cerebrovascular and/or lower aorta/lower limb territories
  • Severe diabetic retinopathy (laser procedure, eye surgery for diabetes complication and intravitreal injection associated with specific drug delivery and/or their combinations
2 years after the randomization and dissemination of health-related messages
Reimbursement claims of medications of special interest and visits to general practitioners and to specialists in cardiology, nephrology and diabetology
Tidsramme: 6 months and 2 years after randomization and dissemination of health-related messages
Change in Reimbursement claims of medications of special interest and visits to general practitioners and to specialists in cardiology, nephrology and diabetology
6 months and 2 years after randomization and dissemination of health-related messages
Biological characteristics
Tidsramme: 2 years before and after randomization and dissemination of health-related messages
Changes in biological results of: lipids, liver and renal functions, blood cell count, HbA1c, CRP , Blood chemistry and Blood and urine urea
2 years before and after randomization and dissemination of health-related messages
Impact on medical costs
Tidsramme: 2 years after randomization and dissemination of health-related messages

Changes between groups:

  • in euros of patients healthcare costs,
  • in type of costs (consultation, hospitalisation, etc),
  • in euros of the intervention impact,
  • in QALY of cost-effectiveness
2 years after randomization and dissemination of health-related messages

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Nantes University Hospital

Samarbeidspartnere

Hospices Civils de Lyon
University Hospital, Toulouse
University Hospital, Tours
Santé publique France-InVS (Institut National de Veille sanitaire)
Biogroup Laboratoire de biologie médicale

Etterforskere

  • Hovedetterforsker: Samy Hadjadj, MD, Nantes university hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juni 2026

Primær fullføring (Antatt)

1. juni 2029

Studiet fullført (Antatt)

1. juni 2032

Datoer for studieregistrering

Først innsendt

18. mai 2026

Først innsendt som oppfylte QC-kriteriene

2. juni 2026

Først lagt ut (Faktiske)

9. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • RC25_0253
  • 2025-A01341-48 (Registeridentifikator: IDRB)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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